Overview
- 9 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-08-16.
At a glance
Inspections
9
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Aug 2018 – 16 Aug 2018 | Foods & Cosmetics | 483 | View 483 → |
| 1 Dec 2016 – 4 Jan 2017 | Foods & Cosmetics | 483 | View 483 → |
| 1 Aug 2016 – 29 Aug 2016 | Foods & Cosmetics | 483 | View 483 → |
| 4 Apr 2016 – 7 Apr 2016 | Foods & Cosmetics | Clean | |
| 8 Nov 2012 | Not recorded | 483 | View 483 → |
| 4 Jan 2012 | Not recorded | 483 | View 483 → |
| 14 Jun 2011 | Not recorded | 483 | View 483 → |
| 27 Apr 2010 | Not recorded | Clean | |
| 18 Sep 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2018
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Marinee Flores-Marrero, Eduardo Carbonell
16 Aug 2018
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Marinee Flores-Marrero, Eduardo Carbonell
16 Aug 2018
21 CFR 110.40(a)
Materials and workmanship
Cited by Marinee Flores-Marrero, Eduardo Carbonell
4 Jan 2017
21 CFR 110.80(a)(1)
Inspection, segregation, handling of raw materials
Cited by Lissette Paiz, Alexander B Anderson
Investigators
FDA investigators tied to this site in the record.
State Agency3 insp.
Lissette Paiz2 insp.
Marinee Flores-Marrero1 insp.
Eduardo Carbonell1 insp.
Alexander B Anderson1 insp.
Aaron F Coleman1 insp.
Ruth A Williams1 insp.
Karen M Rodriguez1 insp.
Jennifer Lalama1 insp.
Michael C Lombardi1 insp.
Kelly M Byers1 insp.
Heather M Bullock1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 417(d)(1)(A) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.80(b)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(13) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Spicepak, Inc.'s 7 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat